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Efficacy of Telerehabilitation in Patients With Degenerative Meniscal Injury

Sponsor
Muğla Sıtkı Koçman University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05233839
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to compare the home exercise program performed with video-based telerehabilitation in patients with degenerative meniscal injury, and the home exercise program performed with one-on-one training in the hospital with conventional methods.

Condition or Disease Intervention/Treatment Phase
  • Other: Telerehabilitation
  • Other: Paper Based Rehabilitation
 N/A

Detailed Description

Conventional rehabilitation (CR) practices will be applied to the first study group. Telerehabilitation (TR) application will be applied to the second study group. It is aimed to evaluate the patients in terms of pain, functionality, quality of life and exercise compliance.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised controlled trialRandomised controlled trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Telerehabilitation and Conventional Rehabilitation on Clinical Outcomes and Exercise Compliance in Patients With Degenerative Meniscal Injury
Anticipated Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telerehabilitation (TR)

The TR group will be followed up through the application within the 8-week home exercise program.

Other: Telerehabilitation
Application based video home exercise for the degenerative meniscus injury
Active Comparator: Paper Based Rehabilitation (PBR)

The PBR group will be followed up through the paper instruction within the 8-week home exercise program.

Other: Paper Based Rehabilitation
Paper instruction based home exercise for the degenerative meniscus injury

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale (VAS) [Change from Baseline VAS at 8 weeks]

    On a 10 cm straight line or numerical scale (0: no pain, 10: unbearable pain).

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Change from Baseline WOMAC at 8 weeks]

    WOMAC consists of 3 main headings: pain intensity, stiffness, and physical function. The total score ranges from 0 (no disability) to 96 (complete disability).

  3. SF-12 [Change from Baseline SF-12 at 8 weeks]

    SF 12 is a self-evaluation scale. It consists of seven items. Its score ranged from 0 to 100, with higher scores indicating better physical and mental health functioning.

  4. Muscle Strength Test with Lafayette Hand Held Dynamometer [Change from Baseline Dynamometer Value at 8 weeks]

    It is an objective muscle strength measurement tool. Measurements are made 3 times. A rest of 120 seconds is given between measurements. The highest measured value is noted.

  5. Proprioception Measurement with Baseline Bubble Inclinometer [Change from Baseline Inclinometer Value at 8 weeks]

    The "absolute angle difference", which is the difference between the targeted angle and the angle realized by the patient in each repetition, is recorded. The arithmetic mean of the absolute angle difference of 3 repetitions is the result data.

Secondary Outcome Measures

  1. EARS [Change from Baseline EARS at 8 weeks]

    In order to observe the individual's adaptation to exercise, the motivation levels of the patients regarding the exercise program are evaluated with the exercise diary prepared by the researchers of the study. It is scored between 0 to 24. Higher scores indicate greater adherence.

  2. TSUQ [Change from Baseline TSUQ at 8 weeks]

    It consists of 21 items. With this survey, the satisfaction levels and usability of individuals using the telemedicine service are evaluated. The total score is scored between 17 and 85. Higher scores indicate higher satisfaction and usability.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male and female patients aged 18 - 65 years

  • Having been diagnosed with degenerative meniscus injury by an orthopedist by MRI examination

  • Having signed the consent form

Exclusion Criteria:

  • Situations that will prevent assessments or communication with the individual

  • Having an operation due to degenerative meniscus injury problem

  • Orthopedic and neurological problems that would prevent evaluation and/or treatment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Muğla Sıtkı Koçman Training and Research Hospital Muğla Menteşe Turkey 48000

Sponsors and Collaborators

  • Muğla Sıtkı Koçman University

Investigators

  • Principal Investigator: İsmet Tümtürk, BSc, Ege University
  • Principal Investigator: Cem Yalın Kılınç, PhD, Muğla Sıtkı Koçman University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatih Ozden, Principal Investigator, Muğla Sıtkı Koçman University
ClinicalTrials.gov Identifier:
NCT05233839
Other Study ID Numbers:
  • Mugla
First Posted:
Feb 10, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatih Ozden, Principal Investigator, Muğla Sıtkı Koçman University
Degenerative meniscus injury
Telerehabilitation

Study Results

No Results Posted as of Mar 2, 2022